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A randomised, open-label trial of a Multimodal Intervention (Exercise, Nutrition and Anti-inflammatory Medication) plus standard care versus standard care alone to prevent / attenuate cachexia in advanced cancer patients undergoing chemotherapy.
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2015
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Physical ActivityChemoprevention StrategyCancer ManagementMultimodalityExercise OncologyNon-pharmacological InterventionOncologyExerciseMetronomic TherapyClinical TrialsRandomized Controlled TrialCancer MetabolismCancer ResearchHealth SciencesOpen-label TrialCancer CachexiaStandard CareMultimodal InterventionCancer TreatmentLung CancerPalliative CareMuscle WastingMedicineMultimodality Therapy
9628 Background: The pathophysiology of cancer cachexia is multi-factorial consisting of muscle wasting, negative protein and energy balance, and systemic inflammation. There is no established treatment for cachexia, paradoxical to the importance of this condition in limiting oncology treatment. New approaches are needed to address the complexity of the syndrome and to challenge the accepted therapeutic nihilism. To treat cachexia optimally it has been argued that a multimodal intervention is necessary to enable the multi factorial pathophysiology to be targeted. Integral to this is targeting inflammation as the main driver of cachexia. Methods: An international, multicentre randomised phase II study was conducted. Eligible patients had advanced lung cancer or pancreatic cancer and were due to start palliative chemotherapy. Patients were randomised (1:1 ratio) to receive either a multimodal intervention (exercise, anti-inflammatories, energy dense nutritional supplements combined with dietary advice) or standard cancer care. Primary outcome measures were feasibility of the intervention assessed by compliance and enrolment. Secondary outcomes examined weight, physical activity (using ActivPAL) and CT based muscle mass. Means and standard deviations (SD) are reported. Results: Forty-six patients were recruited from three regional cancer center’s (Glascow (UK), Trondheim and Oslo (Norway). Overall compliance was > 54% in all components of the intervention. Patients’ in the treatment arm weight increased (0.91% (SD 2.46)), whilst those in the control arm lost weight (-2.12% (SD 2.50)), p < 0.001 (N = 41). Patients in the control arm lost 2.2% more muscle than the treatment arm, p = 0,69. There were no statistical significant differences in physical activity in the patients that had repeated measurements of physical activity with ActivPal (n = 22). Conclusions: A multimodal cachexia intervention is feasible and improves weight in patients with incurable lung or pancreatic cancer. Based on these exciting findings, a definitive phase III study is now underway. Clinical trial information: NCT01419145.